U.S. patent application number 10/169065 was filed with the patent office on 2003-03-27 for collecting bag.
Invention is credited to Leisner, Henrik, Olsen, Eskil Hoelland.
Application Number | 20030060786 10/169065 |
Document ID | / |
Family ID | 26068753 |
Filed Date | 2003-03-27 |
United States Patent
Application |
20030060786 |
Kind Code |
A1 |
Olsen, Eskil Hoelland ; et
al. |
March 27, 2003 |
Collecting bag
Abstract
A flange for a medical collecting bag having an aperture
allowing bodily fluids or exudates to enter the bag, wherein the
flange has an inner rim delimiting the aperture therein, and
wherein the flange has a central area encircling the aperture which
area has a predetermined weakening line pattern wherein the force
needed for removing the bag flange from the skin or a body side
member is smaller than the force needed for breaking the weakening
lines enables a simple gradual enlargement of the aperture of an
ostomy device for adaptation of the aperture to the size of the
stoma or for adaptation of the aperture to the size of a wound and
a complete removal of the bag flange when substituting the bag.
Inventors: |
Olsen, Eskil Hoelland;
(Humlebaek, DK) ; Leisner, Henrik; (Gentofte,
DK) |
Correspondence
Address: |
JACOBSON HOLMAN PLLC
400 SEVENTH STREET N.W.
SUITE 600
WASHINGTON
DC
20004
US
|
Family ID: |
26068753 |
Appl. No.: |
10/169065 |
Filed: |
July 3, 2002 |
PCT Filed: |
January 26, 2001 |
PCT NO: |
PCT/DK01/00062 |
Current U.S.
Class: |
604/342 ;
604/339 |
Current CPC
Class: |
A61F 5/448 20130101;
A61F 5/443 20130101 |
Class at
Publication: |
604/342 ;
604/339 |
International
Class: |
A61F 005/44 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 28, 2000 |
DK |
PA 2000 00154 |
Oct 30, 2000 |
DK |
PA 2000 01364 |
Claims
1. A flange for a medical collecting bag having an aperture
allowing bodily fluids or exudates to enter the bag, wherein the
flange has an inner rim delimiting the aperture therein, wherein
the flange has a central area encircling the aperture which area
has a predetermined weakening line pattern wherein the force needed
for removing the bag flange from the skin or a body side member is
smaller than the force needed for breaking the weakening lines, and
wherein the weakening pattern is in the form of punched or cut
dots, slots or interrupted rectilinear or curved lines.
2. A flange as claimed in claim 1, wherein the weakening pattern is
in the form of an interrupted helical line starting from the inner
rim of the flange.
3. A flange as claimed in claim 1, wherein the weakening pattern is
in the form of a number of interrupted essentially concentric lines
surrounding the aperture of the second flange.
4. A flange as claimed in claim 1 wherein the weakening pattern is
in the form of a combination of helical or concentric lines and
radial lines.
5. A flange as claimed in claim 1 wherein the weakening pattern is
in the form of concentric lines and wherein the weakening pattern
has at least one interruption in a radial zone from the aperture
for receiving the stoma.
6. A medical appliance comprising a body side member comprising a
flange in the form of an adhesive wafer for securing the appliance
to a patient's skin, said wafer having an aperture allowing bodily
fluids or exudates to enter the appliance, and an optionally
separately exchangeable collecting bag secured to the body side
member for collecting fluids or excretions, wherein the flange has
an inner rim defining the aperture therein and a central area
encircling the aperture which area has a predetermined weakening
pattern wherein the force needed for removing the bag flange from
skin is smaller than the force needed for breaking the weakening
lines, and wherein the weakening pattern is in the form of punched
or cut dots, slots or interrupted rectilinear or curved lines.
7. An medical collecting bag having a bag flange having an aperture
allowing bodily fluids or exudates to enter the appliance, the bag
comprising coupling means for releasable coupling and sealing to
corresponding coupling means fixedly connected to a body side
member comprising an adhesive wafer for securing the body side
member to a patient's skin, said wafer having an aperture allowing
bodily fluids or exudates to enter the appliance, wherein the bag
flange has an inner rim defining the aperture therein, wherein the
flange has a central area encircling the aperture and having a
predetermined weakening line pattern wherein the force needed for
removing the bag flange from the body side member is smaller than
the force needed for breaking the weakening lines, and wherein the
weakening pattern is in the form of punched or cut dots, slots or
interrupted rectilinear or curved lines.
8. An collecting bag as claimed in claim 6 or 7 wherein the central
area having a predetermined weakening line pattern does not show
adhesive properties.
9. A medical appliance comprising a body side member comprising an
adhesive wafer for securing the appliance to a patient's skin, said
wafer having an aperture allowing bodily fluids or exudates to
enter the appliance, and a separately exchangeable collecting bag
having a bag flange having an aperture allowing bodily fluids or
exudates to enter the appliance, wherein the body side member
comprises first coupling means being fixedly connected to the body
side member and the collecting bag comprises corresponding second
coupling means adapted for releasable coupling and sealing to the
body side member, wherein the bag flange has an inner rim defining
the aperture therein and a central area which area has a
predetermined weakening line pattern wherein the force needed for
removing the bag flange from the body side member is smaller than
the force needed for breaking the weakening lines, and wherein the
weakening pattern is in the form of punched or cut dots, slots or
interrupted rectilinear or curved lines.
10. An appliance or bag according to any of claims 6-9 in the form
of an ostomy appliance or bag or a wound care appliance or bag.
11. An appliance or bag as claimed in claim 10 in the form of an
ostomy appliance or bag.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to a medical appliance
comprising a body side member comprising an adhesive wafer for
securing the appliance to the patient's skin, said wafer or pad
having an aperture allowing bodily fluids or exudates to enter the
appliance, and an optionally separately exchangeable collecting bag
secured to the body side ostomy member for collecting fluids or
excretions.
BACKGROUND OF THE INVENTION
[0002] In connection with surgery for a number of diseases in the
gastrointestinal tract a consequence is, in many cases, that the
colon, the ileum or the urethra is exposed surgically and the
patient is left with an abdominal stoma and the effluents or waste
products of the body, which are conveyed through these organs, are
discharged through the artificial orifice or opening and are
collected in a collection bag, which is usually adhered to the skin
by means of an adhesive wafer or plate having an inlet opening for
accommodating the stoma. Also in connection with a fistula which
has developed between an internal organ and the abdominal surface,
the patient will have to rely on an appliance to collect the bodily
material emerging from such opening. Collecting bags may also be
used for collecting exudates from a wound or collection of bodily
material in connection with post operation or drainage
purposes.
[0003] Such appliances are well known and may be two-piece or
one-piece appliances. In both types of appliances, a body side
member is attached to the wearer's abdomen, and optionally a
collecting member or bag is attached to the body side member for
collecting exudates from the stoma or wound in case of a two-piece
appliance.
[0004] When using one-piece appliances, the whole appliance,
including the adhesive wafer or pad securing the appliance to the
skin is removed and replaced by a fresh appliance. When using
two-piece appliances, the body side member is left in place for
several days, and only the collecting member or bag is
replaced.
[0005] The service time of the body side ostomy member depends on
the amount and aggressiveness of the exudates and of the tightness
between the ostomy and the body side ostomy member.
DESCRIPTION OF THE RELATED ART
[0006] The service time of ostomy appliances may be reduced for
several reasons. Due to the aggressiveness of the exudates, the
adhesive material of the adhesive wafer may deterioriate and give
access to the skin for the exudates. This may call for a change of
appliance in order to protect the skin. Furthermore, a leakage
around the stoma may give rise to appearance of unpleasant
materials or odours at the abdomen of the patient which may give
rise to skin problems as well as embarrassing situations. In order
to increase the service time of especially ostomy appliances it has
been proposed to adapt the size of the aperture of the adhesive
wafer to the size of the actual stoma. One-piece ostomy appliances
and body side members of two-piece ostomy appliances are normally
offered having adhesive wafers having a range of sizes of apertures
for better adaptation to the size of the actual stoma and the
adhesive wafer is often provided with a cutting guide typically
having series of concentric printed lines having an indication of
the diameter thereof for facilitating a more accurate customisation
using e.g. scissors.
[0007] GB Patent Application No. 2 017 501 discloses a device for
sealing an ostomy bag to the skin of a patient which device
comprises a sheet of material capable of adhering to the skin of a
patient and having a slit or cut extending as a spiral or the like.
An aperture may then be produced in the sheet by unwinding the coil
defined by the slit. The sheet may be of a gelatinous material
having a basis of Karaya gum and/or another hydrophilic
material.
[0008] The appliances disclosed in GB Patent Application No. 2 017
501 are one-piece appliances.
[0009] U.S. Pat. No. 3,604,421 discloses a one piece disposable bag
having a variable size opening surrounded by separately removable
concentric annular strips for forming an opening of variable
diameter. However U.S. Pat. No. 3,604,421 is silent with respect to
the problems associated with removal of all of the bag when
substituting the bag.
[0010] These two references are silent with respect problems
concerning a complete removal of the bag flange of the appliances
when substituting the bag and both teach the presence of a central
disc to be removed before using the appliance.
[0011] In connection with two-piece appliances, the size of the
aperture of the collecting bag for receiving a stoma is often
greater than the size of the apertures of the commonly used body
side members, and there is a considerable risk of access of
exudates to the distal surface of the adhesive wafer of the body
side member. This opens for chemical attack on the adhesive from
the "back" and may furthermore give rise of soiling or
contamination the distal surface of the body side member,
especially in connection with ileostomies and colostomies. This may
reduce the wearing time of the body side member and furthermore
give rise to problems when substituting the collecting bag with a
fresh as the coupling area may have to be cleaned in order to
ensure a proper coupling and sealing of the fresh bag and also to
ensure that residues giving rise to unpleasant odours are not left
on the body side member. Altogether there is a considerable risk of
having to exchange the body side member before its technical
service time has been exhausted.
[0012] It has been found that these drawbacks may be alleviated by
the present invention.
SUMMARY OF THE INVENTION
[0013] The invention relates in its broadest aspect to a medical
appliance comprising a body side member comprising a flange in the
form of an adhesive wafer for securing the appliance to a patient's
skin, said wafer having an aperture allowing bodily fluids or
exudates to enter the appliance, and an optionally separately
exchangeable collecting bag secured to the body side member for
collecting fluids or excretions, wherein the flange has an inner
rim defining the aperture therein and a central area encircling the
aperture which area has a predetermined weakening pattern.
[0014] The invention further relates to a medical appliance
comprising a body side member comprising an adhesive wafer for
securing the appliance to a patient's skin, said wafer having an
aperture allowing bodily fluids or exudates to enter the appliance,
and a separately exchangeable collecting bag having a bag flange
having an aperture allowing bodily fluids or exudates to enter the
appliance, wherein the body side member comprises first coupling
means being fixedly connected to the body side member and the
collecting bag comprises corresponding second coupling means
adapted for releasable coupling and sealing to the body side
member, wherein the bag flange has an inner rim defining the
aperture therein and a central area encircling the aperture which
area has a predetermined weakening pattern.
[0015] Furthermore, the invention relates to an ostomy collecting
bag having a bag flange having an aperture allowing bodily fluids
or exudates to enter the appliance, the bag comprising coupling
means for releasable coupling and sealing to corresponding coupling
means fixedly connected to a body side member comprising an
adhesive wafer for securing the body side member to a patient's
skin, said wafer having an aperture allowing bodily fluids or
exudates to enter the appliance, wherein the bag flange has an
inner rim defining the aperture therein and a central area
encircling the aperture which area has a predetermined weakening
pattern.
[0016] Still further, the invention relates to a flange for a
medical collecting bag in the form of a substantially annular
flange having an inner rim defining an aperture therein and a
central area encircling the aperture which area has a predetermined
weakening pattern
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The invention is described more in detail with reference to
the drawings in which
[0018] FIG. 1 shows an embodiment of a collecting bag according to
the invention having a flange having a predetermined weakening line
in the form of a helix,
[0019] FIG. 2 shows a section of the embodiment shown in FIG. 1
along the line A-A,
[0020] FIG. 3 shows the embodiment shown in FIG. 1 seen from the
side,
[0021] FIG. 4 shows the embodiment shown in FIG. 1 with a part of
the helix detached from the flange,
[0022] FIG. 5 shows another embodiment of a flange for a collecting
bag according to the invention having a predetermined weakening
line in the form of concentric lines,
[0023] FIG. 6 shows a further embodiment of a flange for a
collecting bag according to the invention having a predetermined
weakening line in the form of a combination of helical and radial
lines,
[0024] FIG. 7 shows a further embodiment of a collection bag
according to the invention having a flange having a predetermined
weakening line in the form of a helix and a coupling means,
[0025] FIG. 8 shows a section of the embodiment shown in FIG. 7
along the line B-B, and
[0026] FIG. 9 shows a still further embodiment of a flange for a
collecting bag according to the invention having a predetermined
weakening line in the form of concentric lines.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
[0027] The invention relates to a medical appliance comprising a
body side member comprising a flange in the form of an adhesive
wafer for securing the appliance to a patient's skin, said wafer
having an aperture allowing bodily fluids or exudates to enter the
appliance, and an optionally separately exchangeable collecting bag
secured to the body side member for collecting fluids or
excretions, wherein the flange has an inner rim defining the
aperture therein and a central area encircling the aperture which
area has a predetermined weakening pattern wherein the force needed
for removing the bag flange from skin is smaller than the force
needed for breaking the weakening lines.
[0028] Such an appliance of the invention including a collecting
bag as an integral unit (not exchangeable) may be used as a
one-piece ostomy appliance or for wound, post operation or drainage
purposes offering a simple and effective alleviation of the
above-mentioned drawbacks.
[0029] Furthermore, the present invention relates to a medical
appliance comprising a body side member comprising an adhesive
wafer for securing the appliance to a patient's skin, said wafer
having an aperture allowing bodily fluids or exudates to enter the
appliance, and a separately exchangeable collecting bag having a
bag flange having an aperture allowing bodily fluids or exudates to
enter the appliance, wherein the body side member comprises first
coupling means being fixedly connected to the body side member and
the collecting bag comprises corresponding second coupling means
adapted for releasable coupling and sealing to the body side
member, wherein the bag flange has an inner rim defining the
aperture therein and a central area encircling the aperture which
area has a predetermined weakening line pattern wherein the force
needed for removing the bag flange from the body side member is
smaller than the force needed for breaking the weakening lines.
[0030] The predetermined weakening line pattern renders it possible
to adapt the aperture of a flange of an ostomy collection bag to
the size of the actual stoma leading to a better protection of the
skin or the distal surface of the adhesive wafer of the body side
member reducing the contact with the aggressive exudates from a
stoma and thus overcoming the above mentioned drawbacks.
Furthermore, it is simple to adapt the aperture of the flange by a
gradual enlargement for adaptation to the size of the stoma by
tearing off a part of the flange along the inner rim using the
fingers without having to rely on the use of tools.
[0031] Usually medical appliances such as ostomy appliances having
an adhesive wafer for securing the appliance to a patient's skin
are provided with skin-friendly adhesive which is preferably
covered by a protecting cover or release liner which may for
instance be siliconized paper. It does not need to have the same
contour as the dressing, e.g. a number of dressings may be attached
to a larger sheet of protective cover. The protective cover is not
present during the use of the dressing of the invention. However,
in accordance with a preferred embodiment of the invention a
protecting cover is present for protecting the adhesive surface
before use and during adaptation of the appliance to the individual
ostomate.
[0032] The skin-friendly adhesive may be any skin-friendly adhesive
known per se, e.g. an adhesive comprising hydrocolloids or other
moisture absorbing constituents for prolonging the time of use. The
adhesive may e.g. be of the type disclosed in those disclosed in
U.S. Pat. No. 4,367,732.
[0033] It is preferred according to the invention that there is a
difference of the breaking strength of the flange and of the
protective cover and that such difference is controlled so as to
ensure that the breaking strength of the protective cover is lower
than the breaking strength of the flange in order to enable a
adaptation of the size of the aperture without removing the release
liner. Thus, any unintended contact reducing the binding strength
of the adhesive is avoided as is contamination with bacteria. Such
difference in breaking strength is preferably obtained by
controlling the pattern of weakening lines leaving minor "bridging"
areas in the paper than in the flange when producing the weakening
lines.
[0034] The aperture of the flange of a bag of the invention may
thus be adapted to the actual shape of the stoma. This opens for a
combination of the desired cleaning effect comparable with the
cleaning obtained from the "scraping" against the outer surface of
the stoma by the inner rim of the adhesive wafer when exchanging a
traditional one-piece ostomy appliance with the advantage of
leaving the body side member of a two-piece appliance on the
abdomen of the ostomate for a longer span of time.
[0035] When the bag is attached to the body side member, the flange
thereof furthermore protects distal surface of the body side member
and increases the service time and also reduces the soiling
thereof.
[0036] The pattern of weakening fines may be any convenient pattern
of e.g. in the form of punched or cut dots, slots or interrupted
rectilinear or curved lines weakening the annular flange in a
manner enabling removal of parts thereof from the inner rim of the
flange. The pattern may be produced using any suitable process
known per se for producing such penetrations of a sheet material
such as cutting or punching.
[0037] The depth of cuts depends of the nature of the material and
may penetrate only partially through the thickness of the flange
although it is preferred that it penetrates completely through the
flange at the rim of the aperture. It is preferred that weakening
line penetrates completely through the thickness of the flange only
leaving minor "bridging" areas being easily breakable for enlarging
the aperture.
[0038] In one embodiment of the invention, the weakening pattern is
in the form of an interrupted line pattern.
[0039] In a preferred embodiment of the invention, the weakening
pattern is in the form of an interrupted helical line starting at
the inner rim of the flange.
[0040] In another preferred embodiment of the invention, the
weakening line pattern is in the form of a number of interrupted
concentric lines surrounding the aperture in the second flange.
[0041] In a preferred embodiment of the invention, the weakening
line pattern is in the form of a combination of helical or
concentric lines and radial lines rendering it easy to adapt to the
size and contour of the aperture to the stoma.
[0042] It is preferred to provide the outer part of the flange,
outside the weakening pattern with perforations in an essentially
circular zone corresponding of the kind disclosed in WO 00/30576
for further reducing the risk of leakage due to formation of
canals.
[0043] The central area of the flange having an area having a
predetermined weakening line pattern may according to another
embodiment of the invention show only a weak adhesiveness. Thus, it
is preferred that the adhesiveness of the central area is so weak
that the force for removing the flange from the skin or the body
side member is smaller that the force needed for breaking the
weakening lines. This renders it possible to ensure a good contact
to the skin or the back of the body side member being desirable for
protecting the same against soiling and also ensures that the bag
may be substituted without breaking the remaining weakening lines
which may give rise to spilling of waste material situated on the
flange inside the bag. In one embodiment of the invention it is
ensured that the central area shows very low adhesiveness by
utilising a flange having an adhesive having very low tack/peel
values and it is also considered an embodiment of the invention to
provide a flange not having adhesive in the central area. For
practical reasons it is often less complicated to apply a layer of
adhesive on all of the surface of the flange and then, afterwards
to partially or fully disable the adhesive properties in the
central area by applying an optionally perforated non-detachable
cover layer covering the central area or e.g. by covering the
adhesive layer of the central area partly or fully with a release
agent such as talc. The cuts, dots, slots or interrupted
rectilinear or curved lines preferably penetrates a cover
layer.
[0044] In an especially preferred embodiment of the invention, the
weakening pattern of the flange is in the form of concentric lines
wherein the weakening pattern has at least one interruption in a
radial zone from the aperture for receiving the stoma. Along this
zone, the tearing resistance is higher than the force necessary for
breaking the bridges connecting consecutive rings of the flange.
This feature allows for a safe removal of an ostomy collecting bag
together with all of the adhesive flange without leaving one or
more rings on the body side member. The radial direction of such
relative enforcement is preferably in the direction of a protruding
part or ear facilitating the removal of the bag. In this
embodiment, it is not necessary to rely on a weaker adhesiveness in
the weakening line area in order to ensure a full removal of the
bag and its flange as discussed above.
[0045] In another aspect, the invention relates to a medical
collecting bag having a bag flange having an aperture allowing
bodily fluids or exudates to enter the appliance, the bag
comprising coupling means for releasable coupling and sealing to
corresponding coupling means fixedly connected to a body side
member comprising an adhesive wafer for securing the body side
member to a patient's skin, said wafer having an aperture allowing
bodily fluids or exudates to enter the bag, wherein the bag flange
has an inner rim delimiting the aperture therein, and wherein the
flange has a central area having a predetermined weakening line
pattern wherein the force needed for removing the bag flange from
the body side member is smaller than the force needed for breaking
the weakening lines.
[0046] The coupling means may be any suitable coupling means known
per se for coupling of ostomy body side members to ostomy
collecting bags, e.g. a mechanical coupling such as matching
coupling rings or it may be in the form of a first flange secured
to the body side member and a second flange secured to the
collecting bag, the second flange being adapted for removable and
adhesive coupling and sealing to the first flange. Such second
flange is suitably the above mentioned bag flange which then has
outer adhesive areas for coupling to the body side member in
addition to the central area.
[0047] The first and the second flanges are preferably formed as
discs of a cellular plastic material, which provides a good shock
absorbing and resilient action and also has the effect that the
weight of the collecting system can be kept down.
[0048] In a third aspect, the invention relates to a flange for an
ostomy collecting bag having a flange having an aperture allowing
bodily fluids or exudates to enter the appliance, wherein the
flange has an inner rim delimiting the aperture therein, and
wherein the flange has a central area having a predetermined
weakening line pattern wherein the force needed for removing the
bag flange from the body side member is smaller than the force
needed for breaking the weakening lines.
[0049] In the present context, the term "distal" in connection with
a surface of an appliance is used to designate the surface thereof
being opposite to the skin contacting surface thereof.
[0050] The term "medical" in connection with a bag or use is used
to designate use in connection with collection of bodily fluids or
excretions from a surface area or an aperture emerging on the
surface of a living being. An appliance according to the invention
may thus be a bag for placing on the skin for collecting wound
exudates, bodily material in connection with post operation or
drainage purposes or excretions from the urethra or the intestine
which has been lead to an artificial opening in connection with an
injure or surgery. A preferred use is for ostomy appliances or
wound care appliances, mostly preferred ostomy appliances.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0051] Reference is made to FIG. 1 of the drawings showing an
embodiment of an ostomy appliance according to the invention. The
bag 1 comprises a flange 2 secured to the collecting bag which
flange has an inner rim defining an inlet aperture 3 therein for
receiving a stoma, and wherein the flange has a central area 4
having a predetermined weakening line pattern 5 in the form of a
helical line starting from the inner rim thereof. The collecting
bag 1 for collection of materials emerging from the stoma is
adapted for coupling to a body side member for securing the bag 1
around the stoma on a patient's abdominal wall. The bag 1 may
either be closed as shown or be openable at the bottom for
intermittent emptying of its contents. The central area of the
flange 2 is in this embodiment surrounded by a substantially
annular part of the flange acting as coupling means for connecting
the bag 1 sealingly with a body side member (not shown). Such a
body side member comprises a body side member which is designed to
be adhered to the patient's skin by means of a skin-friendly
adhesive applied on the back of the body side member. The body side
member carries first coupling means which in connection with this
embodiment is in the form of a first flange or body side member
flange, in which is formed an aperture and which is designed for
receiving an adhesive coupling to the flange 2.
[0052] The body side member flange may be secured to the body side
member with a layer of adhesive applied in a substantially annular
connecting section having an internal diameter corresponding to
that of the aperture in the body side member flange and having an
external diameter so that a rim portion of the flange protrudes
beyond the layer of an adhesive. Of course, the flange may also be
secured to the body side member through other means, for example by
welding.
[0053] The bag flange and a body side member flange may, for
example, be moulded in a water-repellent cellular plastics
material, such as ethylene vinyl acetate (EVA) or polyurethane
(PUR), with closed cells so that the cellular plastic material does
not absorb liquid.
[0054] The bag itself may made from any material known per se for
the production of ostomy appliances.
[0055] On the side facing away from the bag, the flange is coated
over substantially all its surface with a thin, washable layer of
adhesive (not shown), which may, for example, be a hydrogel
adhesive, an acrylate adhesive or an adhesive of the hot-melt type.
The layer of adhesive is applied in a thin layer, partly to keep
thickness low, and partly to maintain the flexibility and
resilience of the bag flange. This application may be effected, for
example, by coating, spraying or application in a suitable pattern.
When the bag is delivered, the layer of adhesive is covered by a
release liner.
[0056] The bag flange 2 preferably has a protruding part or ear 8
facilitating the removal of the bag by providing a handle or grip
for handling the bag. In such an area, the adhesive is preferably
covered by a cover layer.
[0057] FIG. 2 shows a sectional view of the embodiment of a bag of
the invention shown in FIG. 2 is taken along the line A-A before
preparing the bag for application and indicated the cuts 5.
[0058] FIG. 3 shows the same embodiment, seen from the side. In
FIG. 4, the bag is being prepared for application and a part 9 of a
strip defined by a helical weakening line has been removed from the
plane of the flange and is ready for tearing off leaving a bag
having an aperture better adapted to the stoma than conventional
standardised bags.
[0059] FIG. 5 shows an embodiment of a flange according to the
invention having a weakening line pattern 6 in the form of a number
of interrupted concentric lines surrounding the aperture 3 in the
flange.
[0060] FIG. 6 shows a further embodiment of a flange according to
the invention having a the weakening line pattern 7 in the form of
a combination of helical or concentric lines and radial lines
surrounding the aperture 3 in the flange.
[0061] FIG. 7 shows another embodiment of an ostomy appliance
according to the invention. In this embodiment the bag 1 comprises
a flange 2 secured to the collecting bag which flange has an inner
rim delimiting an inlet aperture 3 therein for receiving a stoma,
and wherein the flange has a central area 4 having a predetermined
weakening line pattern 5 in the form of a helical line starting
from the inner rim thereof. In this embodiment, the flange is
surrounded by coupling means 9 in the form of a coupling ring for
connecting the bag 1 sealingly with a body side member.
[0062] FIG. 8 shows a sectional view of the embodiment of FIG. 6
along the line B-B shoving the coupling ring 9 secured to the bag
outside the central area.
[0063] FIG. 9 shows a preferred embodiment of a flange according to
the invention. The central area of the flange 2 has a weakening
line pattern 6 in the form of a number of interrupted concentric
lines surrounding the aperture 3 and is surrounded by a
substantially annular part 10 of the flange acting as coupling
means for connecting a bag sealingly to a body side member. The
weakening pattern has at least one interruption 11 in a radial zone
from the aperture for receiving the stoma towards the outer
periphery and an ear 8 for facilitating the removal of the bag.
Such relative enforcement may be in the form of an interruption of
the pattern of the weakening line, shown as two sets of "renforcing
lines" 11 interrupting the line pattern 6. Outside the annular part
10 is preferably an outer part 12 being delimited from the annular
part 10 by perforations 13 of the kind disclosed in WO 00/30576 in
an essentially circular zone for further reducing the risk of
leakage.
* * * * *